BGX COVID-19 RT-PCR BX100

  • Box of 100
  • SKU: BGXCOVID
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BGX COVID-19 RT-PCR Qualitative Detection Kit

BGX COVID-19 RT-PCR is a real time RT-PCR kit for qualitative detection of novel corona virus (SARS-CoV-2) nucleic acids (RNA) in human Nasopharyngeal and Oropharyngeal swab specimens. Result can be used for diagnosis of COVID-19 infection. Targets dual regions of SARS-CoV-2 nucleocapsid gene (N1 & N2) as per CDC recommendation. Internal control Primers & Probe are provided in the panel.

  • Qualitative detection of SARS-CoV-2  
  • One-step Multiplex Real time RT-PCR
  • Primers and Probes targeting dual regions of SARS-CoV-2 "N" gene as per US-CDC
  • US-FDA EUA

Accuracy

 

  • Analytical accuracy of 7.5 RNA copies per μL 
  • No cross-reactivity with other respiratory viruses 
  • Highly specific and sensitive

Ease of Operation 

  • Includes all the reagents required for RT-PCR 
  • Provided with Positive Control and Primers & Probe for Internal Control 
  • Assay Time: 90 mins 
  • Open platform compatible with all major multi-channel RT-PCR instruments

Salient Features

 

  • Specific detection of SARS CoV-2 nucleocapsid (N1 & N2) gene 
  • Limit of detection (LoD): 7.5 RNA copies per μL 
  • No cross-reactivity with other respiratory viruses 
  • Simple workflow

Specimen 

 

  • Nasopharyngeal swab specimen 
  • Oropharyngeal swab specimen

Kit Componenets

 

  • BGX RT Mix 
  • BGX Master Mix 
  • BGX Primers & Probes Set 
  • Positive Control 
  • Nuclease Free Water

WARNINGS AND PRECAUTIONS:

For Use Under An Emergency Use Authorization Only For in vitro diagnostic use For Prescription Use Only

Disclaimer

The BGX COVID-19 RT-PCR has been validated, but validation of this test has not been independently reviewed by FDA. Review under the Emergency Use Authorization (EUA) program is pending. Distributed in accordance with FDA’s guidance, “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency, Section IV.C.2.” Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. 

A statement such as “the test has been validated but FDA’s independent review of this validation is pending,” should be included in test reports to healthcare providers.

 

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